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Home-Based Interventions for Adolescents With Type 1 Diabetes (R34)

31 maj 2017 uppdaterad av: Deborah Ellis, Ph.D., Wayne State University

Translating Home-Based Interventions for Adolescents With Poorly Controlled TID

Adolescents with T1D and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. The purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, Fit Families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. If successful, Fit Families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The proposed study is a planning grant in which MST will be adapted for delivery by community health workers and will be conducted in collaboration with CHASS, a community agency providing health care to underserved residents of Detroit with diabetes. The new intervention, Fit Families (FF), will be tested in a pilot randomized controlled trial in order to evaluate FF feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. These steps will allow for finalization of intervention content and other trial parameters in preparation for a larger R18 dissemination trial.

The design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. Half will be randomly assigned to the treatment intervention, Fit Families plus standard medical care, and the other half will be assigned to standard medical care alone. Families who are randomized to FF receive intensive, home-based family therapy delivered by a community health worker (CHW) for approximately six months.

Studietyp

Interventionell

Inskrivning (Faktisk)

49

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48201
        • Children's Hospital of Michigan

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

10 år till 17 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • a current hemoglobin A1c(HbA1c) of >9.0%
  • an average HbA1c of >9.0% during the past year
  • reside in the metro Detroit tri-county area
  • diagnosed with Type 1 diabetes for at least one year
  • aged 10-17
  • patient of Children's Hospital of Michigan Diabetes Clinic

Exclusion Criteria:

  • severe mental impairment/thought disorder
  • Active suicidality
  • Active homicidality
  • Diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Fit Familes plus Standard Medical Care
Participants will receive the intervention Fit Families plus Standard Medical Care which is an adaptation of Multisystemic Therapy for Type 1 Diabetes delivered by Community Health Workers (CHWs) in addition to standard medical care.
Beteende: Fit Families plus Standard Medical Care
Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
Inget ingripande: Standard Medical Care
Standard medical care is provided at Children's Hospital of Michigan consistent with the standards for the care of children with T1D outlined by the American Diabetes Association.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Metabolic Control: Hemoglobin A1c (HbA1c)
Tidsram: Change from Baseline at 7 months, Change from Baseline at 9 months
retrospective measure of blood glucose control, encompasses the previous 2-3 months
Change from Baseline at 7 months, Change from Baseline at 9 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DKA admissions and emergency room (ER) Visits: hospital information systems data extraction, Service Utilization Questionnaire (SUQ)
Tidsram: Change from Baseline at 7 months, Change from Baseline at 9 months
The number of patient visits to acute care settings represents a significant health care cost in this high-risk population.
Change from Baseline at 7 months, Change from Baseline at 9 months
Quality of life
Tidsram: Change from Baseline at 7 months, Change from Baseline at 9 months
44 scale item designed to tap life satisfaction, diabetes impact and diabetes related worries in adolescents.
Change from Baseline at 7 months, Change from Baseline at 9 months
Regimen Adherence: Diabetes Management Scale (DMS), Glucose Meter Downloads
Tidsram: Change from Baseline at 7 months, Change from Baseline at 9 months
The DMS assesses a broad range of management behaviors, such as insulin management, dietary management, blood glucose monitoring, symptom response, and parent assistance/supervision. Glucose meters only assess blood glucose monitoring, but are empirically linked to metabolic control
Change from Baseline at 7 months, Change from Baseline at 9 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wayne State University

Samarbetspartners

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Utredare

  • Huvudutredare: Deborah A Ellis, Ph.D, Wayne State University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2014

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Faktisk)

1 juli 2016

Studieregistreringsdatum

Först inskickad

4 september 2014

Först inskickad som uppfyllde QC-kriterierna

15 september 2014

Första postat (Uppskatta)

17 september 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juni 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 maj 2017

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1R34DK102091-01 (U.S.S. NIH-anslag/kontrakt)
  • R34DK102091 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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